Events

Rappel de cobas e 801 syringe plunger issue

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Roche Diagnostics GmbH.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    22805
  • Date de mise en oeuvre de l'événement
    2018-04-13
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Cause
    The manufacturer has received complaints describing an issue with the syringe plunger on the cobas e 801 module prewash syringe assembly. investigations determined that the issue may also occur on the cobas e 801 module r1 or r2 reagent assembly. depending on the affected syringe, r1, r2 or prewash, liquids may not be pipetted correctly due to the syringe plunger being damaged. depending on how the seal pieces are assembled, it is possible that the plunger is mounted in a tilted position, which applies mechanical stress to the plunger. during the cobas e 801 module initialization steps when the largest stokes happen, the plunger may crack leading to an impaired syringe function.
  • Action
    Product to be modified

Device

cobas e 801 syringe plunger issue

Manufacturer

Roche Diagnostics GmbH